DM Studdert, MA Hall. NEJM 2022; 387: 1533-1537. Medical Malpractice Law — Doctrine and Dynamic
This article reviews the topic of malpractice and the hurdles for plaintiffs to establish liability. Some of the interesting points:
“Patients lose about 80% of medical malpractice trials.3 However, fewer than 1 in 20 claims end in courtroom verdicts; about one third are settled out of court with a payment to the patient, and the remainder are dropped or dismissed.3“
“NPDB data reveal a remarkable phenomenon: the number of paid claims against physicians has decreased by 75% in the past 20 years.” The potential reasons include tort reform, greater openness about medical errors may have reduced patients’ inclination to sue, better medical care (no evidence of this), and incomplete NPDB data. With regard to incomplete data, this can occur with “corporate shielding” in which institutions assume liability and payment responsibility in claims against physicians, thus averting reporting requirements).
MM Mello, WE Parmet. NEJM 2021; 385: 1153-5. Open Access: Public Health Law after Covid-19 This commentary describes changes in public health law as a result of the COVID-19 pandemic.
“More than 1000 suits challenged orders shuttering businesses, banning indoor worship services, restricting travel, and mandating mask wearing.”
“In 1905 in Jacobson v Massachusetts, the Supreme Court upheld a vaccination mandate…Judicial review, the Court found is limited to …’arbitrary and oppressive in particular cases”
“Most courts..have …granted considerable deference to health officials…Courts have been more receptive, however, to challenges relating to religious liberty and the scope of executive authority.”
“The court in an unsigned opinion ruled that the CDC had overstepped its authority [with an eviction ban] under the Public Health Service Act (PHSA)…Congress…must pass legislation to impose one or to clarify that the CDC may impose one.”
“The decisions with regard to free exercise of religion suggest that health orders will face strict scrutiny if they regulate religious practices more strictly than any secular activity that courts deem similar.”
My take: This article makes clear that “while emergencies can lead to abuses of authority, …in their [Courts] zeal to protect religious liberty and constrain executive action, courts may be leaving officials with fewer tools to fight Covid-19 and the next pandemic.”
Mr. Ayer was a U.S. attorney and principal deputy solicitor general in the Reagan administration and deputy attorney general in the George H.W. Bush administration.
[The Supreme Court’s] recent history suggests that it lacks a majority of justices with sufficient concern about the basic continuity and integrity of the law or the ability of government to function…it seems ready to cast aside certain constitutional rights, the court today regularly gives sweeping new interpretations to other rightsand invokes them to radically narrow certain government powers that were until quite recently uncontroversial, including, for example, powers related to public safety or our democratic process...
Perhaps most unexpected and disturbing were decisions elevating rights of religious assembly over local public-safety rules related to Covid-19 that limited the ability to gather. Yet throughout our history, in matters of public health, the powers of local government have usually been at their apex. That did not matter here — nor did the fact that Chief Justice Roberts was among the dissenters.
“On November 25, 2020, … the U.S. Supreme Court, by a 5-to-4 vote, undermined states’ ability to control that pandemic.” (Roman Catholic Diocese of Brooklyn v. Cuomo)
Initially, most courts rejected challenges to restrictions imposed by governors during the pandemic. “Initially, most courts rejected these claims, citing the Supreme Court’s 1905 decision in Jacobson v. Massachusetts, which upheld a Cambridge, Massachusetts, regulation mandating smallpox vaccination during an outbreak.”
After the appointment of Justice Amy Coney Barrett, ” there was now a 5-to-4 majority willing to block limits on religious services.” This was based on the rationale that it is unlawful to “single out houses of worship for especially harsh treatment” and that “even in a pandemic, the Constitution cannot be put away and forgotten.”
In dissent, “Justice Stephen Breyer pointed to epidemiologic evidence that in-person worship may pose a greater risk than shopping and other activities that were less stringently regulated to argue that the Court should defer to state officials.”
“The Court’s eagerness to intervene even though New York’s orders were no longer in effect and its failure to consider epidemiologic evidence in determining which activities are comparable to worship will serve as a warning” against “state orders that impose tighter measures on worship…[and] suggests that states will not be able to act before super-spreader events occur or as long as other states take a more lax approach.”
The author note that “although courts should not abdicate their role during a pandemic, they also should not rush to assume an expertise they lack.”
“[The] most important legacy may be the dethroning of Jacobson…[which] has been the key precedent supporting vaccine mandates and other public health laws….With Jacobson apparently sidelined, the future of many public health laws, including and especially vaccine mandates, appears perilous.”
While the FDA is responsible for overseeing the safety of pharmaceuticals and veracity of marketing, its authority does not extend to the practice of medicine. This enables the widespread practice of using medications for “off-label” purposes. Physicians can use approved drugs for nonapproved uses. FDA regulations have restrained marketing of off-label uses of prescription medications by pharmaceutical representatives.
However, a recent appellate ruling in United States v. Caronia has stated “the government cannot prosecute pharmaceutical manufacturers…for speech promoting the lawful, off-label use of an FDA-approved drug.” According to this perspective article, the ruling stemmed from the argument that refusing to “allow the free flow of information would result in …limitations, and side effects of the drug.”
At stake is whether the ability of the FDA to combat false or misleading speech. In addition, limiting the FDA’s authority may lead to fewer studies documenting the effectiveness of medications for various indications. If the medication is approved for one use and there are no constraints on marketing, there will be little incentive to complete additional studies.